FDA Discourages Use of Laparoscopic Morcellation to Treat Uterine Fibroids

The FDA is discouraging clinicians from using laparoscopic power 
morcellation for uterine fibroids because the procedure can cause 
undiagnosed uterine cancer to spread, the agency announced on 
Thursday. It stopped short of banning the procedure.

An FDA analysis found that roughly 1 in 350 women undergoing 
hysterectomy or myomectomy for fibroids has unsuspected uterine 
sarcoma. In such cases, laparoscopic morcellation, which involves 
cutting tissue into smaller pieces for easier removal, can spread the 
cancer within the abdomen and pelvis.

Roughly 50,000 of these procedures are done in the U.S. annually, and 
the FDA has received about a dozen reports of cancer being spread.

“We think, in general, the procedure should not be performed,” said 
the FDA’s William Maisel, adding that “there still may be individual 
patients who benefit.”

The FDA is outrightly recommending against laparoscopic morcellation 
in women with suspected or known uterine sarcoma.

Asked to comment, NEJM Journal Watch Women’s Health editor-in-chief 
Andrew Kaunitz said, “The current controversy … is focusing 
attention on tissue extraction alternatives, including manual or 
electronic morcellation within an endoscopic bag, as well as specimen 
removal either through laparoscopic-aided mini-laparotomy or through a 
vaginal incision. In addition, some hospitals have instituted policies 
on the use of electric morcellation during minimally invasive 
gynecologic surgeries.”

FDA MedWatch safety alert (Free)
By Kelly Young

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